Abstract
BackgroundWe describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min.ResultsThe chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery.ConclusionThe developed stability-indicating liquid chromatography process was well applied to established tablet formulations.
Highlights
We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations
Optimal response and symmetrical peak shapes for DEC and DEH were achieved with an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” having column slot temperature of 25°C using 0.1M Dipotassium hydrogen phosphate (K2HPO4), pH 4.5-acetonitrile (55:45, v/v) as mobile phase with isocratic flow type run of 1.0 mL/min
UV detection with 265 nm setting was found as the best fit for an optimal peak response and to quantity DEH and DEC
Summary
We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. The DEH and DEC fixed-dose formulation was available as oral drops [5], capsule [6], suspension [7] and tablet [8]. Pharmaceutical analysis was often performed out to verify that the drug substance or medication satisfies the two most critical attributes of quality: safety and effectiveness [9]. Manufacturing corporations need both qualitative including quantitative studies to guarantee that its raw materials fulfil the requisites and that the finished material is of high quality. Quantification of DEH in blend with other drugs using UV spectroscopy [16], HPTLC [17] and Saroja et al Future Journal of Pharmaceutical Sciences (2021) 7:108
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
